Trial Review

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.


With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


Reset your password and enable multi-factor authentication (MFA)


For ANZCTR account holders: to help ensure the cyber safety of your account, you’ll need to reset your password and set-up multi-factor authentication (MFA) as per the instructions below.


  1. Go to the Login page, click ‘reset password’ and follow the instructions.
  2. Check your email for the link to set a new password.
  3. Create a new password that meets requirements.
  4. Return to the Login page and enter your new password. A verification code will be sent to your email.
  5. Check your email for the code and enter it on the Login page. If the code is entered incorrectly, you can re-enter the correct one or request a new one.

Learn more about MFA and its importance on the Australian Signals Directorate website.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618002000280
Ethics application status
Approved
Date submitted
3/12/2018
Date registered
13/12/2018
Date last updated
13/12/2018
Date data sharing statement initially provided
13/12/2018
Date results provided
13/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Nasal Functions of Operated Unilateral Cleft Lip and Palate Patients Compared with Skeletal Class III Individuals
Scientific title
Nasal Functions of Operated Unilateral Cleft Lip and Palate Patients Compared with Skeletal Class III Individuals
Secondary ID [1] 296765 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cleft Lip-Palate 310650 0
Alveolar Cleft 310686 0
Condition category
Condition code
Oral and Gastrointestinal 309362 309362 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Respiratory 309363 309363 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Hours
Description of intervention(s) / exposure
The nasal resistance data were collected with anterior rhinomanometry method for unilateral Cleft Lip and Palate patients (study group) at least 6 months after the surgical procedure and also for control group. Anterior Rhinomanometry (RM) is a non-invasive dynamic test showing nasal airflow resistance with two tubes placed at the nostrils, is widely used to evaluate the expiration and resistance of the upper airways objectively and quantitatively.
Before evaluation, the patients who rested in the upright position for 20 minutes. For removing the mucosal congestion because of ‘nasal cycle phenomenon’, nasal decongestant spray was applied to both nostrils and waited for 15 minutes. Nasal airflow was measured (in ml/sec) by active anterior rhinomanometry at the pressure of 150 Pa for each nostril separately, during five repetitive hard inspiration and expiration. The nasal resistance for nasal sides and total nasal resistance were measured in Pa/L/sec.
Intervention code [1] 313075 0
Early Detection / Screening
Comparator / control treatment
The control group included individuals had the healthy and non-cleft skeletal class III control group participants corresponded in age and sex to the study group
Control group
Active

Outcomes
Primary outcome [1] 308319 0
Comparison of the study group and the control group in terms of nasal resistance that were collected with Anterior Rhinomanometry method
Timepoint [1] 308319 0
At least post-operative 6 months
Secondary outcome [1] 354604 0
Nil
Timepoint [1] 354604 0
Nil

Eligibility
Key inclusion criteria
Non-syndromic cleft lip and palate patients with cleft lip reconstruction, cleft palate repair surgery, and alveolar cleft grafting surgery were completed and at least 6 months after the last surgery.
The control group included skeletal class III individuals corresponded in age and sex to the patients of study group individually
Minimum age
10 Years
Maximum age
21 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The exclusion criteria for both study and control groups were acute or chronic upper airway infections, nasal or orthognathic surgery history, any syndrome or craniofacial anomaly, surgical or not palatal expansion history, or pharyngeal and nasal pathologies such as tonsillitis or polyposis, and smokers.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Case control
Timing
Prospective
Statistical methods / analysis
Statistical analysis was performed using SPSS 20.0 software. For normality tests, Kolmogorov-Smirnov test was used. For determining the differences between the groups, the Student t test and Mann Whitney U test were used. P values of “<0.05” were considered statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/09/2016
Date of last participant enrolment
Anticipated
Actual
30/06/2017
Date of last data collection
Anticipated
Actual
30/09/2017
Sample size
Target
32
Accrual to date
Final
32
Recruitment outside Australia
Country [1] 21093 0
Turkey
State/province [1] 21093 0
Erzurum

Funding & Sponsors
Funding source category [1] 301343 0
University
Name [1] 301343 0
Ataturk University
Country [1] 301343 0
Turkey
Primary sponsor type
University
Name
Ataturk University
Address
Atatürk University Faculty of Dentistry Department of Oral and Maxillofacial Surgery
Main Campus of Ataturk University, 25040 Yakutiye, ERZURUM
Country
Turkey
Secondary sponsor category [1] 301011 0
None
Name [1] 301011 0
Address [1] 301011 0
Country [1] 301011 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302082 0
Regional Ethical Review Board of Ataturk University Faculty of Dentistry
Ethics committee address [1] 302082 0
Ethics committee country [1] 302082 0
Turkey
Date submitted for ethics approval [1] 302082 0
09/03/2016
Approval date [1] 302082 0
13/06/2016
Ethics approval number [1] 302082 0
16/084

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89066 0
Dr Mert Ataol
Address 89066 0
Mersin University Faculty of Dentistry Department of Oral and Maxillofacial Surgery Çiftlikköy Campus, 33343, Yenisehir, MERSIN
Country 89066 0
Turkey
Phone 89066 0
+905333686222
Fax 89066 0
Email 89066 0
[email protected]
Contact person for public queries
Name 89067 0
Mert Ataol
Address 89067 0
Mersin University Faculty of Dentistry Department of Oral and Maxillofacial Surgery Çiftlikköy Campus, 33343, Yenisehir, MERSIN
Country 89067 0
Turkey
Phone 89067 0
+905333686222
Fax 89067 0
Email 89067 0
[email protected]
Contact person for scientific queries
Name 89068 0
Mert Ataol
Address 89068 0
Mersin University Faculty of Dentistry Department of Oral and Maxillofacial Surgery Çiftlikköy Campus, 33343, Yenisehir, MERSIN
Country 89068 0
Turkey
Phone 89068 0
+905333686222
Fax 89068 0
Email 89068 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• only researchers who provide a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?
• individual participant data underlying published results only

What types of analyses could be done with individual participant data?
• any purpose

When can requests for individual participant data be made (start and end dates)?
From:
Immediately following publication, no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• unrestricted access

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.